Insulin Dose Stable | Injection of insulin Daily Dose Multiple | Continuous subcutaneous infusion of insulin
Item
all subjects will be on stable doses of insulin using mdi or csii (basal insulin-
boolean
C0021641 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0199782 (UMLS CUI [2,1])
C2348070 (UMLS CUI [2,2])
C0439064 (UMLS CUI [2,3])
C0393124 (UMLS CUI [3])
Basal insulin Lantus | Basal insulin Levemir | Bolus Humalog | Bolus NovoLog | Bolus Apidra | Bolus Humulin R
Item
lantus or levemir; bolus- humalog, novolog, apidra, humulin regular), for three months prior to enrollment.
boolean
C0650607 (UMLS CUI [1,1])
C0876064 (UMLS CUI [1,2])
C0650607 (UMLS CUI [2,1])
C1314782 (UMLS CUI [2,2])
C1705509 (UMLS CUI [3,1])
C0528249 (UMLS CUI [3,2])
C1705509 (UMLS CUI [4,1])
C0939412 (UMLS CUI [4,2])
C1705509 (UMLS CUI [5,1])
C1654827 (UMLS CUI [5,2])
C1705509 (UMLS CUI [6,1])
C0306371 (UMLS CUI [6,2])
Insulin-Dependent Diabetes Mellitus Duration
Item
type 1 diabetes duration > 3 years.
boolean
C0011854 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
6.5% ≤ a1c ≤ 9.0%.
boolean
C0202054 (UMLS CUI [1])
Age
Item
male or female ≥ 18 and ≤ 65 years of age.
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance | Investigational New Drugs Oral Daily Dose Multiple | Placebos | Glucose measurement by monitoring device
Item
ability and willingness to adhere to the protocol including multiple daily oral doses of study drug or placebo and week-long cgm wear.
boolean
C0525058 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C2348070 (UMLS CUI [2,3])
C0439064 (UMLS CUI [2,4])
C0032042 (UMLS CUI [3])
C0202048 (UMLS CUI [4])
Serum LDL cholesterol measurement
Item
ldl-c > 100 mg/dl.
boolean
C0428474 (UMLS CUI [1])
colesevelam | Adherence Dosage Instructions | Administration of medication Drug Interactions | Gender | Oral Contraceptives Containing Ethinyl Estradiol | Oral Contraceptives Containing Norethindrone
Item
willing to adhere to colesevelam dosage instructions, including administration of drugs with a known interaction at least 4 hours prior to colesevelam. females using oral contraceptives containing ethinyl estradiol and norethindrone must be willing to administer their doses at least four hours prior to using colesevelam.
boolean
C0541155 (UMLS CUI [1])
C1510802 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1442085 (UMLS CUI [2,3])
C3469597 (UMLS CUI [3,1])
C0687133 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4])
C0009905 (UMLS CUI [5,1])
C0332256 (UMLS CUI [5,2])
C0015011 (UMLS CUI [5,3])
C0009905 (UMLS CUI [6,1])
C0332256 (UMLS CUI [6,2])
C0028356 (UMLS CUI [6,3])
Retinal Disease Advanced | Patient need for Laser procedure | Patient need for Vitrectomy
Item
advanced retinopathy needing laser procedure or vitrectomy.
boolean
C0035309 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C1562720 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C0042903 (UMLS CUI [3,2])
Kidney Disease Unstable | Creatinine measurement, serum | Macro Proteinuria | Albumin excretion rate measurement
Item
unstable nephropathy (serum creatinine > 2.0 mg/dl or macroproteinuria (albumin excretion rate > 200 ug/ min).
boolean
C0022658 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C2984010 (UMLS CUI [3,1])
C0033687 (UMLS CUI [3,2])
C0585937 (UMLS CUI [4])
Hypoglycemia Severe Unknown
Item
any unexplained severe hypoglycemia within the last six months.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Body mass index
Item
bmi > 35.0.
boolean
C1305855 (UMLS CUI [1])
Therapeutic procedure Pre-existing | Bile acid sequestrants | Glyburide | Thyroxine | Phenytoin | Warfarin
Item
currently on a pre-existing bile acid sequestrant therapy, glyburide, levothyroxine, phenytoin, or warfarin.
boolean
C0087111 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C2917337 (UMLS CUI [2])
C0017628 (UMLS CUI [3])
C0040165 (UMLS CUI [4])
C0031507 (UMLS CUI [5])
C0043031 (UMLS CUI [6])
Pregnancy | Pregnancy, Planned | Contraceptive methods Lacking
Item
pregnant, planning a pregnancy, or not using an adequate method of birth control.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Condition Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Limited | Condition Limiting Informed Consent Validity
Item
any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C2349101 (UMLS CUI [3,4])
Pharmaceutical Preparation modifies Glucose level | Exception Insulin | Adrenal Cortex Hormones | Antidiabetics Oral
Item
use of any medication known to modify glucose values other than insulin (i.e. corticosteroids or oral antidiabetics).
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0428548 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
Intestinal Obstruction
Item
a history of bowel obstruction.
boolean
C0021843 (UMLS CUI [1])
Serum Triglyceride Measurement
Item
serum triglyceride (tg) concentrations >500 mg/dl.
boolean
C0542495 (UMLS CUI [1])
Pancreatitis Hypertriglyceridemia Induced
Item
a history of hypertriglyceridemia induced pancreatitis.
boolean
C0030305 (UMLS CUI [1,1])
C0020557 (UMLS CUI [1,2])
C0205263 (UMLS CUI [1,3])